Thursday , 30 November 2023

Analytical Method Development and Validation for the Simultaneous Estimation of Cefadroxil and Ambroxol Hydrochloride by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Devanapelly Shashikantha Rao*
Lecturer, Department of Chemistry, C.K.M. Arts and Science College, Warangal- 506006, Andhra Pradesh, India

A Simple and rapid stability indicating RP-HPLC method was developed for the simultaneous determination of Cefadroxil and Ambroxol in bulk and pharmaceutical dosage form. A chromatographic separation of the two drugs was achieved with a Symmetry C18 (4.6 × 250 mm, 5 μm partical size, make: Xterra) analytical column using sodium acetate trihydrate buffer (adjusted to pH 4.5 by glacial acetic acid):Acetonitrile (50:50%v/v) in isocratic mode at a flow rate of 1 mL/min and column at ambient temperature. The detection was monitored at 243 nm using a PDA detector. The stressed samples were analyzed for the degradation study in acid, base, peroxide, thermal, photolytic and validated as per ICH guideline. This proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The described method shows excellent linearity over a range of 10-50 μg/mL of Cefadroxil and 1.2-6.0 μg/mL of Ambroxol. The correlation coefficient for Cefadroxil and Ambroxol were 0.999 and a0.999 respectively. The mean recovery values for Cefadroxil and Ambroxol were 99.9% and 100%respectively. The limit of detection for Cefadroxil and Ambroxol were 0.005 μg/mL and 0.005 μg/mL and the limit of quantification were 0.018 μg/mL and 0.017 μg/mL respectively. The retention times was observed at 2.3mins, 3.2 mins for Cefadroxil and Ambroxol respectively. The Robustness Study and percentage of assay of the formulation were found within limit as per ICH guidelines.
Key words: UV spectrophotometer, Cefadroxil, Ambroxol, High performance liquid chromatography, validation, stability indicating method, stress conditions.

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